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manan ☆ Ahmedabad, 2010-12-17 07:38 (5658 d 16:02 ago) (edited on 2010-12-29 15:32) Posting: # 6313 Views: 13,339 |
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Dear all I have a few general querry which almost many of you might be having a deep idea about. can anyone please help on below few points:
You replies and comments will be highly anticipated. Thank you Edit: Category changed. [Jaime] |
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Helmut ★★★   Vienna, Austria, 2010-12-17 15:10 (5658 d 08:30 ago) @ manan Posting: # 6316 Views: 12,068 |
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Dear Manan! I'm not sure whether you are the right place here.  Read Wikipedia's articles on generics and patent first. The innovator gets a patent for the drug itself, not for (any) to-be-marketed formulation. In most legislations the drug is protected for 20 years. That's the reason innovators try to run their studies fast. If they got approval (US: NDA, EU: MA) within 10 years, their formulation is protected for the remaining 10 years the drug is patented. Simple math. If you are interested in which drugs will come off-patent, consider subscribing to DrugPatentWatch. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Phaneendra.K ☆ 2010-12-28 16:49 (5647 d 06:51 ago) @ manan Posting: # 6347 Views: 11,553 |
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Dear Manan, As to my knowledge, a patent is the exclusive right given to the innovator for 20 years from the date of filing and NDA. But as research goes on a patent can be challenged withing this period without infringement. Then a exclusivity can move to the one who has challenged it along with the patentee, provided his formulation has been proven better. Regarding expiry of patents and the future of BA-BE studies, i must say that as NDDS are progressing there is a scope for many new formulations including the existing ones, so many Investigational products for BABE. Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Jaime] — Thanks and Regards, PK |
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Jaime_R ★★ Barcelona, 2010-12-28 17:05 (5647 d 06:35 ago) @ Phaneendra.K Posting: # 6348 Views: 11,650 |
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Dear Phaneendra! ❝ As to my knowledge, a patent is the exclusive right given to the innovator for 20 years from the date of filing and NDA. Have you read Helmut's post? The innovator's drug is patented, not the formulation (filed in the NDA). Another story are patented drug delivery systems, e.g. the OROS technology from Alza. You may come up with another formulation being BE to an OROS formulation (if the drug is off-patent, of course), but may not use the the same technology, which would be a patent infringement. — Regards, Jaime |
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manan ☆ Ahmedabad, 2010-12-29 06:49 (5646 d 16:51 ago) (edited on 2010-12-29 15:34) @ Jaime_R Posting: # 6349 Views: 11,435 |
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❝ You may come up with another formulation being BE to an OROS formulation (if the drug is off-patent, of course), but may not use the the same technology, which would be a patent infringement. Dear Jamie I read the post on the OROS formulation and the technology used for the preparation is quiet interesting. However, as the cocept used here is osmotic pressure, i hope there will be some changes in the PK profile of the formulation. Do we have any guidline in place for OROS formaultion? can you please let me know in detail about the OROS formulation? i searched FDA and EMEA guidances but i wasnt able to find it. Many thanks in advance Edit: Subject line changed. [Jaime] |
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Jaime_R ★★ Barcelona, 2010-12-29 16:30 (5646 d 07:10 ago) @ manan Posting: # 6350 Views: 11,605 |
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Dear Manan! ❝ Dear Jamie Jaime, not Jamie. ❝ [...] However, as the cocept used here is osmotic pressure, i hope there will be some changes in the PK profile of the formulation. Of course, that's the idea. For an example plasma profile see here. ❝ Do we have any guidline in place for OROS formaultion? ❝ can you please let me know in detail about the OROS formulation?  !What about this one? ❝ i searched FDA and EMEA guidances but i wasnt able to find it. There are no specific guidelines. Why do you think there should be one? An osmotic pump is just a biopharmaceutical technology and therefore within the scope of modified release guidelines. — Regards, Jaime |
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manan ☆ Ahmedabad, 2010-12-30 08:29 (5645 d 15:11 ago) @ Jaime_R Posting: # 6356 Views: 11,427 |
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Dear Jaime I think OROS should follow modified or extended release giudances. I do have one article to share with you. but i am not able to find any upload link for PDF files here.   |
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Jaime_R ★★ Barcelona, 2010-12-30 15:12 (5645 d 08:28 ago) @ manan Posting: # 6358 Views: 11,388 |
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Dear Manan! ❝ I think OROS should follow modified or extended release giudances. OK, as I already said above: ❝ ❝ There are no specific guidelines. Why do you think there should be one? An osmotic pump is just a biopharmaceutical technology and therefore within the scope of modified release guidelines. ❝ I do have one article to share with you. but i am not able to find any upload link for PDF files here.
— Regards, Jaime |
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Helmut ★★★ Vienna, Austria, 2011-01-01 16:25 (5643 d 07:14 ago) @ manan Posting: # 6378 Views: 11,489 |
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Dear Manan! ❝ […] i am not able to find any upload link for PDF files here. There is none; please see FAQ#11. Sharing literature (unless published under a Creative Commons license) would make BEBAC (not you as the uploader!) legally responsible for copyright violation. I know that other forums take liberties with it, but that’s their business. Thank you for your understanding and cooperation. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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ElMaestro ★★★ Denmark, 2010-12-29 23:40 (5646 d 00:00 ago) @ manan Posting: # 6351 Views: 11,504 |
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Dear Manan, ❝ now this is quiet intersting. Many people say that in a couple of years, a lot of actual existing patents will expire. Then what is the scope of Generics and BA-BE studies in the future or lets say coming 5-10 years? According to my crystal ball (which does not give references; unfortunately I bought a cheap one that isn't even validated) the amount of generic submissions in the EU is expected to increase during the next 3-4 years and then gradually decrease. If this is true, I'd see an argument for BA/BE studies following the same trend. On the other hand, I have recently spoken to people in life cycle management operations who have indicated that the use of BA/BE sudies is going to increase within originator companies as part of efforts to protect medicines with expiring patents. EM. — Pass or fail! ElMaestro |
Ing. Helmut Schütz